By Carmelina G. Allis – Earlier this month, FDA updated the 1998 guidance document regarding changes to a PMA device that may or may not qualify for a 30-Day Notice. This updated document provides new examples of manufacturing changes that may be submitted under a 30-Day …
By Kurt R. Karst – FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related …
By Riëtte van Laack – On Friday April 22, 2011, a customer slapped Bayer HealthCare LLC (“Bayer”) with a class action suit in California federal court accusing Bayer of falsely and deceptively advertising the benefits of its Phillips Probiotics Colon Health (“PPCH”) supplements. The complaint alleges …
By Cassandra A. Soltis – A recent case issued by the National Advertising Division (“NAD”) of the Better Business Bureau serves as a reminder to advertisers to clearly demarcate claims when multiple products are advertised in the same medium. In Case #5317, the NAD examined the advertisements …
By Jennifer D. Newberger – On April 25, 2011, FDA announced the availability of two guidance documents issued by the Center for Tobacco Products ("CTP"). The first, a final guidance document issued in March 2011, is titled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” …
By Kurt R. Karst – An April 21st letter penned by David Balto, a Senior Fellow at American Progress who focuses on competition policy, intellectual property law and health care, and Michael Carrier, a professor at the Rutgers University School of Law-Camden, and sent to five …
By Ricardo Carvajal - The Atlantic’s second annual Food Summit in Washington, DC brought together speakers and attendees with divergent views on questions of how to ensure sustainability of the food supply, improve the availability and affordability of foods, and address the problem of obesity. On one …
By Kurt R. Karst – A recent report from Leerink Swann LLC analyst Howard Liang, Ph.D. suggests that what appears to be a recent increase in the number of Refuse-to-File (“RTF”) letters issued by FDA to NDA and BLA sponsors – some of which are large, …
Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will be giving the state of the industry address at Q1 Productions’ 2nd Annual Clinical & Regulatory Strategies for Combination Products, which is slated to take place in Baltimore, Maryland from July 11-12, 2011. The potential benefit …
By Ricardo Carvajal – The Senate has adopted legislation that would strengthen criminal penalties "for any individual or corporation that knowingly endangers American lives by contaminating the food supply by distributing misbranded or tainted food products" (see Sen. Leahy's press release here). The legislation provides for …
By John A. Gilbert, Jr. & Peter M. Jaensch – In a press conference at the National Press Club on April 19, 2011, the Administration presented its action plan (“Plan”) to address concerns about the increase in prescription drug abuse. The Plan is entitled: “Epidemic: Responding to …
By William T. Koustas – On Tuesday, April 19, 2011, after years of debate and several public meetings, FDA released the final Risk Evaluation and Mitigation Strategy ("REMS") it will require for all extended-release opioid medications. The final REMS was issued as part of the White …
By Kurt R. Karst – A recent amendment to the America Invents Act (H.R. 1249) introduced by Representative John Conyers (D-MI) and passed by voice vote during a markup of the bill last week by the House Committee on the Judiciary would give The Medicines Company …
By Wes Siegner & Cassandra A. Soltis – There has been a buzz in the trade press and industry over when a company is required under the Federal Food, Drug, and Cosmetic Act ("FDC Act") to submit to the Food and Drug Administration ("FDA") a 75-day …
By Kurt R. Karst – On April 15th, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a Complaint filed last September by ViroPharma Incorporated (“ViroPharma”) in connection with the approval of ANDAs for generic versions …
